Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)
Study Details
Study Description
Brief Summary
The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The primary objective of this observational study is to verify, through a comprehensive geriatric assessment, the health status of a sample of elderly subjects. Short- to medium-term outcomes will also be evaluated through follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| elderly subjects subjects aged 65 years and over |
Other: comprehensive geriatric asssessment
The clinical, biological and functional chararacteristics will be collected in elderly subjects attending the hospitals of partecipating centers.
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Outcome Measures
Primary Outcome Measures
- Change in health conditions [Baseline, 3, 6 and 12 months later]
The prevalence of comorbidities and their risk factors at time of enrolment
- Change in prevalence of polypharmacy [Baseline, 3, 6 and 12 months later]
Number of participants with polypharmacy. Polypharmacy will be defined as being on five or more medications at one time
Secondary Outcome Measures
- Change in frailty condition [Baseline, 3, 6 and 12 months later]
Clinical Frailty Scale (CFS). The CFS divides patients into 9 classes from very fit (CFS=1) to terminally ill (CFS=9)
- Change in functional capacity [Baseline, 3, 6 and 12 months later]
Activity of Daily Living (ADL). A summary score ranges from 0 (low function, dependent) to 6 (high function, independent)
- Change in functional capacity [Baseline, 3, 6 and 12 months later]
Activity of Instrumental of Daily Living (IADL). A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)
- Change in physical performance [Baseline, 3, 6 and 12 months later]
Physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance
- Change of cognitive function score [Baseline, 3, 6 and 12 months late]
Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function
Eligibility Criteria
Criteria
Inclusion Criteria:
- subjects with 65 years or older
Exclusion Criteria:
- no informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS INRCA Hospital | Cosenza | Italy |
Sponsors and Collaborators
- Istituto Nazionale di Ricovero e Cura per Anziani
- Ministry of Health, Italy
Investigators
- Principal Investigator: Andrea Corsonello, MD, IRCCS INRCA, Cosenza, Italy
- Principal Investigator: Simona Ciccone, MD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
- Principal Investigator: Antonio Greco, MD, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
- Principal Investigator: Rodolfo Sardone, MD, IRCCS "Saverio de Bellis", Castellana Grotte (BA), Italy
- Principal Investigator: Fabrizio Giunco, MD, Fondazione Don Carlo Gnocchi, Milano, Italy
- Principal Investigator: Mariacristina Parravano, MD, Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia, Roma, Italy
- Principal Investigator: Marco Lenti, MD, Fondazione Policlinico San Matteo, Pavia, Italy
- Principal Investigator: Rosa Liperoti, MD, Fondazione Policlinico Universitario A. Gemelli, Roma, Italy
- Principal Investigator: Francesca Bruni, MD, Istituto Auxologico Italiano, Milano, Italy
- Principal Investigator: Giuseppe Rengo, MD, Istituti Clinici Scientifici Maugeri, Scientific Institute of Telese Terme (BN), Italy
- Principal Investigator: Milena Fini, MD, Istituto Ortopedico Rizzoli, Bologna, Italy
- Principal Investigator: Luigi Zagra, MD, Istituto Ortopedico Galeazzi, Milano, Italy
- Principal Investigator: Alessandro Nobili, MD, Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INRCA_001_2023